Author of

• 18502

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  P3.02c - Poster Session with Presenters Present (ID 472)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18540

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    P3.02c-038 - First-Line Atezolizumab plus Chemotherapy in Chemotherapy-Naïve Patients with Advanced NSCLC: A Phase III Clinical Program (ID 4956)

    14:30 - 14:30  |  Author(s): T. Asakawa
    • Abstract

    Background:
    First-line treatments for patients with advanced NSCLC include targeted therapies and platinum-based doublet chemotherapy±bevacizumab and/or pemetrexed. Although immunotherapies targeting the PD-L1/PD-1 pathway are available for advanced NSCLC beyond the first line, chemotherapy is a key first-line option for patients, despite poor survival outcomes, highlighting the need for additional treatment options. Atezolizumab, a monoclonal anti–PD-L1 antibody, inhibits the binding of PD-L1 to its receptors PD-1 and B7.1, restoring tumor-specific T-cell immunity. Clinical efficacy has been reported with atezolizumab monotherapy in patients with squamous and nonsquamous NSCLC, with a survival benefit observed across all PD-L1 expression levels. Additionally, Phase Ib data showed the potential for chemotherapy to further enhance responses to atezolizumab, with tolerable safety, in patients with NSCLC. Bevacizumab in combination with atezolizumab may enhance efficacy in non-squamous NSCLC by inhibiting VEGF-mediated immunosuppression. Four global, Phase III, randomized, open-label trials are evaluating atezolizumab+platinum-based chemotherapy±bevacizumab in chemotherapy-naive patients with stage IV NSCLC.
    
    Methods:
    Eligible patients must have stage IV NSCLC, measurable disease (RECIST v1.1) and ECOG PS 0-1 and be chemotherapy naive. Exclusion criteria include untreated CNS metastases, autoimmune disease and prior exposure to immunotherapy. Patients will be enrolled regardless of PD-L1 expression status. Patients randomized to the experimental arm will receive atezolizumab 1200 mg with standard platinum-based chemotherapy in IMpower130 and 131 and also ±bevacizumab in IMpower150 for four or six 21-day cycles, then maintenance with atezolizumab in IMpower130 and 131 and atezolizumab+bevacizumab in IMpower150. In IMpower132, experimental-arm patients will receive atezolizumab+platinum-based chemotherapy+pemetrexed, then maintenance with atezolizumab+pemetrexed. Patients receiving atezolizumab may continue until loss of clinical benefit. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include objective response rate and safety. Evaluation of predictive biomarkers associated with efficacy will be performed.

    Trial	IMpower130	IMpower131	IMpower132	IMpower150
    Histology	Nonsquamous	Squamous	Nonsquamous	Nonsquamous
    Planned enrollment(N)	650	1025	568	1200
    Experimental	Atezolizuma +carboplatin +nab-paclitaxel	Atezolizuma +carboplatin +paclitaxel or Atezolizumab +carboplatin +nab-paclitaxel	Atezolizuma +carboplatin or cisplatin +pemetrexed	Atezolizumab +carboplatin +paclitaxel or Atezolizumab +carboplatin +paclitaxel +bevacizumab
    Comparator	Carboplatin +nab-paclitaxel	Carboplatin +nab-paclitaxel	Carboplatin or cisplatin +pemetrexed	Carboplatin +paclitaxel +bevacizumab
    Stratification factors	Sex Liver metastases Centrally assessed PD-L1 expression by IHC	Sex Liver metastases Centrally assessed PD-L1 expression by IHC	Sex ECOG PS Chemotherapy type (carboplatin vs cisplatin) Smoking status	Sex Liver metastases Centrally assessed PD-L1 expression by IHC
    Identifier	NCT02367781	NCT02367794	NCT02657434	NCT02366143

    ECOG PS, Eastern Cooperative Oncology Group performance status; IHC, immunohistochemistry.
    
    Results:
    Section not applicable
    
    Conclusion:
    Section not applicable